Further information

A Leading Global Pharmaceutical Company, are presently looking to bring in a Senior Regulatory Affairs Consultant to be based in their London Office

Role
*The position is specific to the regulatory support for oncology products which are developed by The Company
*Develop innovative regulatory strategies for product development and approval for assigned oncology products (small molecule and biologics)
*Prepare or facilitate preparation of documents to support regulatory submissions for assigned projects. (except clinical trial applications)
*Participate in relevant team meetings on assigned projects to provide strategic European regulatory input and guidance to teams

Accountabilities
*Maintain a current knowledge of applicable/relevant regulations and guidelines.
*Provide regional regulatory strategic guidance on assigned oncology development and marketed products, which are developed by The Company.
*Plan, manage and execute regulatory activities in territories as required on assigned oncology project/s or to support Director, Regulatory Affairs Oncology in these activities as required except clinical trial applications)
*Serve as the regional representative on relevant multi-functional team meetings including meetings with relevant teams based internationally on assigned projects to provide regulatory input and guidance.
*Advise functional areas regarding content requirements for regulatory submissions in the region and review documents for regulatory submission as required.
*Interface and work closely with EU clinical counterparts to ensure clinical and commercial alignment o support regulatory activities on assigned project/s.
*Interface with regulatory counterparts in affiliate companies in Europe territories to support regulatory activities on assigned projects as required. * Manage and conduct meetings with regulatory authorities.
*Act as a point contact for regulatory authorities for submissions on assigned project/projects.
*Preparation of the Europe contribution to the Regulatory Development Plan for assigned projects, and participate/contribute to discussions on aligned global regulatory development plans.
*Evaluate new and revised regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.
*May be required to undertake due diligence activities
*May be required to supervise or mentor other team members
*May be required to evaluate draft EU regulations/guidance and coordinate organisational review of these/collation of comments for feedback to industry associations

Education and Experience
*BS degree or equivalent in science; advanced degree preferred
*Significant pharmaceutical/biological drug development experience and specifically within a regulatory affairs environment
*Proven European regulatory submissions capability, ideally in both pre-submission and post authorisation activities; this should include experience on oncology projects.
*Experience in interactions with European Regulatory authorities in relation to all aspects of Regulatory activities.
*Detailed knowledge of EU regulations and guidelines on drug development and submissions both pre and post approval including oncology guidelines.
*Knowledge of eCTD.
*Experience working with CROs and/or contractors.
*Good negotiation and communication skills and the ability to work independently and function well in a team-orientated environment.
*Some previous management experience preferred

Are you available or interested?
To Apply:

To apply, please click on the Apply button. Ideally, please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Luke Webber on +44 (0) 207 440 0635 or upload your CV on our website. Full description available on request.

Please note that not all of our vacancies are advertised. To register as a priority candidate, please upload your CV on our website with a short description of what you are looking for or call 0800 988 4437. We will then contact you with relevant roles: www.proclinical.co.uk. We regard all correspondence as confidential.

Proclinical is a specialist Employment Agency and Recruitment Business, providing employment opportunities within major companies in the Pharmaceutical and Biopharmaceutical industries across Europe.

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